By Invitation. After a decade: why we need to protect Section 3(d) of the patent law

Before the 1970s, the Indian Patent Law was on the lines of the British law, allowing foreign companies to make huge profits. Thus, we had among the highest medicines prices.

In the 1970s, after detailed reports of Bakshi Tek Chand and Justice Ayyangar to reform the Indian Patent Law in the interest of its citizens, the Law was amended to protect only process patents, not product patents on medicines and food.

Product patents give an absolute monopoly to the owner, permitting them to charge monopolist exorbitant prices for medicines.

But process patents allow competition, as persons develop better processes to make a product and compete with each other, thereby resulting in lowering of prices for the people.

This happened in India. Several Indian generic companies came up with effective processes and began to compete with the foreign companies.

From a relatively low presence, the Indian generic drugs industry became a dominant player in India and the developing world. By the 1990s, it became the largest supplier of safe and effective anti-retrovirals [to treat HIV] in the developing world. Indian generic pharmaceutical companies were “making in India” not only for Indians but for the rest of the world.

In 1995, after years of negotiations, when India became a signatory to the TRIPS agreement, it was mandated to honour process and product patents on medicines and food from January 1, 2005.

The challenge was to comply with TRIPS and make sure that Indian generics could enter the market and compete, to keep drugs affordable.

We realised by early 2001 that a large number of patents in the US, Europe and Japan (about 76%) were granted for new forms of known substances without any real improvement in therapeutic benefit.

The new forms (a salt or crystal etc.) did not change the active ingredient and its efficacy, but was perhaps better at say, handling of the drug. Despite this, new forms were granted patents in the developed world, and the resultant medicines were exorbitantly priced.

Therefore in 2005, Parliament unanimously passed, cutting across party lines, section 3(d) – so a new form of a known substance could not be patented unless it showed significant enhanced efficacy. Parliament did not define “enhanced efficacy”, but left it to the courts.

This was the bone of contention in the Novartis case. The Supreme Court held that efficacy in section 3 (d) was therapeutic efficacy. Novartis argued that the â-crystalline form of the salt of imatinib, imanitib mesylate (gleevec) had better flow properties, was less hygroscopic, thermodynamically more stable.

The Supreme Court rightly held that these were not elements for determining therapeutic efficacy. Novartis also argued that gleevec was 30% more bioavailable which implied significantly enhanced efficacy. The court held that by itself bioavailability cannot imply higher therapeutic efficacy, which has to be shown by separate experiments.

The Supreme Court in Novartis not only saw the significance of section 3(d) but gave a fuller meaning to it. Had it not been for section 3(d), gleevec and a large number of other new forms of existing medicines would be granted patents. In fact a recent study shows that section 3(d) has been effective in preventing non deserving patents on new forms from being patented.

As we mark a decade of 3(d) and pressure from multinational companies increases on India to change its IP (Intellectual Property) laws, there is reason enough to protect and celebrate section 3(d) and not allow it to be dismantled.

Not just to keep medicines affordable for people in India and overseas, but to ensure only true innovations are rewarded with patent protection.

Anand Grover is a Senior Advocate who argued the Novartis case for the Cancer Patients Aid Association